FDA Product Code QAF: Impedance Plethysmograph, Cranial
Detect Or Measure Variations In Volume In The Cranium, Using Tissue Impedance Properties.
Leading manufacturers include Cerebrotech Medical Systems, Inc..
3
Total
3
Cleared
163d
Avg days
2017
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
233d
recently vs 128d historically
FDA 510(k) Cleared Impedance Plethysmograph, Cranial Devices (Product Code QAF)
3 devices
About Product Code QAF - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QAF since 2017, with 3 receiving FDA clearance (average review time: 163 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QAF Product Code
Recent submissions under QAF have taken an average of 233 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.
QAF devices are reviewed by the Neurology panel. Browse all Neurology devices →